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Just in from Howard’s Desk (wheel chair) …
I just sent a feedback message to med page. How ridiculous it is that the FDA is implementing 25 new actions, in order to help improve the medical device approval dilemma.
I said given the opportunity I would be willing to undertake a position as a lay person in the approval process of medical devices. Providing I could report directly to the president. This would save us, taxpayers, money by eliminating a lot of unnecessary bs. Rest a sure I wouldn’t need 25 new actions, I would get some people off their butts, and work.
All would have written job descriptions, if they didn’t follow them –out.
I would review 510k approvals back dating to 2005 -2011. Make sure all data, studies, etc. were in compliance with the product being approved. If they were not or if there were noticeable problems I would open my ears and listen and hear what doctors may be concerned about, and act accordingly.
There were some well known doctors that expressed concerns about metal on metal hip devices. Concerned about results that may occur if there should be particles shave from friction of these devices, even if they had plastic liners. These Dr’s were ignored and now look at the devastation going on in people’s lives.
Market share and financing seemed to take a precedence over the health and well being of people. This will only change if the bull is taken by the horns.
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Howard Sadwin said:
Another major problem: it seems some important clinical data provided to the FDA for approval of devices, was originated by the companies themselves,or provided by people, Dr’s,hospitals, destributors, consulting firms on the payroll.
Some of these payoffs, don’t deal directly between company and individuals. The Federal goverment is investigating PODs. This is a third party vehicle in which monies can be distributed to Dr’s,hospitals,etc. You can read and get a better understanding of how monies pass hands in some cases to help market these medical devices.
The reading is good for making the hair on your neck raise. Unless we, you, me do something to change an archic system, this will continue to happen over and over.
Market share and financing are important in our economy, but not at the expense of my and your health and well being.
If I am going to be a lab rat, I should make that choice and I should know all the facts as to good and worse case scenerios. That is fair isn’t it ?
Good Points – the world is full of vested interests. The more money you have the deeper it goes.